Consumer-Mediated Data Exchange for Research: Current State of US Law, Technology, and Trust.

A compendium of US laws and regulations offers increasingly strong support for the concept that researchers can acquire the electronic health record data that their studies need directly from the study participants using technologies and processes called consumer-mediated data exchange. This data acquisition method is particularly valuable for studies that need complete longitudinal electronic records for all their study participants who individually and collectively receive care from multiple providers in the United States. In such studies, it is logistically infeasible for the researcher to receive necessary data directly from each provider, including providers who may not have the capability, capacity, or interest in supporting research. This paper is a tutorial to inform the researcher who faces these data acquisition challenges about the opportunities offered by consumer-mediated data exchange. It outlines 2 approaches and reviews the current state of provider- and consumer-facing technologies that are necessary to support each approach. For one approach, the technology is developed and estimated to be widely available but could raise trust concerns among research organizations or their institutional review boards because of the current state of US law applicable to consumer-facing technologies. For the other approach, which does not elicit the same trust concerns, the necessary technology is emerging and a pilot is underway. After reading this paper, the researcher who has not been following these developments should have a good understanding of the legal, regulatory, technology, and trust issues surrounding consumer-mediated data exchange for research, with an awareness of what is potentially possible now, what is not possible now, and what could change in the future. The researcher interested in trying consumer-mediated data exchange will also be able to anticipate and respond to an anticipated barrier: the trust concerns that their own organizations could raise.

Spinal manipulative therapy and exercise for seniors with chronic neck pain.

BACKGROUND CONTEXT: Neck pain, common among the elderly population, has considerable implications on health and quality of life. Evidence supports the use of spinal manipulative therapy (SMT) and exercise to treat neck pain; however, no studies to date have evaluated the effectiveness of these therapies specifically in seniors. PURPOSE: To assess the relative effectiveness of SMT and supervised rehabilitative exercise, both in combination with and compared to home exercise (HE) alone for neck pain in individuals ages 65 years or older. STUDY DESIGN/SETTING: Randomized clinical trial. PATIENT SAMPLE: Individuals 65 years of age or older with a primary complaint of mechanical neck pain, rated ≥3 (0-10) for 12 weeks or longer in duration. OUTCOME MEASURES: Patient self-report outcomes were collected at baseline and 4, 12, 26, and 52 weeks after randomization. The primary outcome was pain, measured by an 11-box numerical rating scale. Secondary outcomes included disability (Neck Disability Index), general health status (Medical Outcomes Study Short Form-36), satisfaction (7-point scale), improvement (9-point scale), and medication use (days per week). METHODS: This study was funded by the US Department of Health and Human Services, Health Resources and Services Administration. Linear mixed model analyses were used for comparisons at individual time points and for short- and long-term analyses. Blinded evaluations of objective outcomes were performed at baseline and 12 weeks. Adverse event data were collected at each treatment visit. RESULTS: A total of 241 participants were randomized, with 95% reporting primary outcome data at all time points. After 12 weeks of treatment, the SMT with home exercise group demonstrated a 10% greater decrease in pain compared with the HE-alone group, and 5% change over supervised plus home exercise. A decrease in pain favoring supervised plus HE over HE alone did not reach statistical significance. Compared with the HE group, both combination groups reported greater improvement at week 12 and more satisfaction at all time points. Multivariate longitudinal analysis incorporating primary and secondary patient-rated outcomes showed that the SMT with HE group was superior to the HE-alone group in both the short- and long-term. No serious adverse events were observed as a result of the study treatments. CONCLUSIONS: SMT with HE resulted in greater pain reduction after 12 weeks of treatment compared with both supervised plus HE and HE alone. Supervised exercise sessions added little benefit to the HE-alone program.

Spinal manipulation, medication, or home exercise with advice for acute and subacute neck pain: a randomized trial.

BACKGROUND: Mechanical neck pain is a common condition that affects an estimated 70% of persons at some point in their lives. Little research exists to guide the choice of therapy for acute and subacute neck pain. OBJECTIVE: To determine the relative efficacy of spinal manipulation therapy (SMT), medication, and home exercise with advice (HEA) for acute and subacute neck pain in both the short and long term. DESIGN: Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00029770) SETTING: 1 university research center and 1 pain management clinic in Minnesota. PARTICIPANTS: 272 persons aged 18 to 65 years who had nonspecific neck pain for 2 to 12 weeks. INTERVENTION: 12 weeks of SMT, medication, or HEA. MEASUREMENTS: The primary outcome was participant-rated pain, measured at 2, 4, 8, 12, 26, and 52 weeks after randomization. Secondary measures were self-reported disability, global improvement, medication use, satisfaction, general health status (Short Form-36 Health Survey physical and mental health scales), and adverse events. Blinded evaluation of neck motion was performed at 4 and 12 weeks. RESULTS: For pain, SMT had a statistically significant advantage over medication after 8, 12, 26, and 52 weeks (P ≤ 0.010), and HEA was superior to medication at 26 weeks (P = 0.02). No important differences in pain were found between SMT and HEA at any time point. Results for most of the secondary outcomes were similar to those of the primary outcome. LIMITATIONS: Participants and providers could not be blinded. No specific criteria for defining clinically important group differences were prespecified or available from the literature. CONCLUSION: For participants with acute and subacute neck pain, SMT was more effective than medication in both the short and long term. However, a few instructional sessions of HEA resulted in similar outcomes at most time points. PRIMARY FUNDING SOURCE: National Center for Complementary and Alternative Medicine, National Institutes of Health.

Screening for postpartum depression among low-income mothers using an interactive voice response system.

This study tested the feasibility of using an interactive voice response (IVR) phone system to screen for postpartum depression among low-income, English- and Spanish-speaking mothers. Newly delivered mothers were interviewed in the hospital. Consenting subjects completed a background questionnaire and were asked to call an automated phone system 7 days postpartum to complete an IVR version of the Edinburgh Postnatal Depression Screen (EPDS). During the phone screen, subjects were branched to different closing narratives based on their depression scores which were later posted to a password protected website. Logistic regression was used to assess relationships between demographic and psychosocial factors, IVR participation, and depression scores. Among 838 ethnically diverse, low income, postpartum mothers, 324 (39%) called into the automated phone screening system. Those who called were more likely to have at least a high school education (OR = 1.63, 95%CI: 1.23, 2.16), be employed (OR = 1.48, 95%CI: 1.08, 2.03) and have food secure households (OR = 1.50, 95%CI: 1.06, 2.13). There was no statistically significant difference between callers and non-callers in terms of marital status, race/ethnicity, parity, or self-reported history of depression. Postpartum depression symptoms were present in 17% (n = 55) and were associated with being single (AOR = 2.41, 95% CI: 1.29, 4.50), first time mother status (AOR = 2.43, 95% CI: 1.34, 4.40), temporary housing (AOR = 2.35, 95% CI: 1.30, 4.26), history of anxiety (AOR = 2.79, 95% CI: 1.69, 6.67), and history of self-harm (AOR = 2.66, 95% C: 1.01, 6.99). Automated phone screening for postpartum depression is feasible among disadvantaged mothers but those with the highest psychosocial risk factors may not choose or be able to access it. IVR could be used to supplement office- and home visit-based screening protocols and to educate patients about mental health resources.

Supervised exercise with and without spinal manipulation performs similarly and better than home exercise for chronic neck pain: a randomized controlled trial.

STUDY DESIGN: Randomized controlled trial using mixed methods. OBJECTIVE: To evaluate the relative effectiveness of high-dose supervised exercise with and without spinal manipulation and low-dose home exercise for chronic neck pain. SUMMARY OF BACKGROUND DATA: Neck pain is a common global health care complaint with considerable social and economic impact. Systematic reviews have found exercise therapy (ET) to be effective for neck pain, either alone or in combination with spinal manipulation. However, it is unclear to what extent spinal manipulation adds to supervised exercise or how supervised high-dose exercise compares with low-dose home exercise. METHODS: Two hundred and seventy patients with chronic neck pain were studied at an outpatient clinic. Patients were randomly assigned one of the following interventions: (1) high-dose supervised strengthening exercise with spinal manipulation (exercise therapy combined with spinal manipulation therapy [ET + SMT]), (2) high-dose supervised strengthening exercise (ET) alone, or (3) low-dose home exercise and advice (HEA). The primary outcome was patient-rated pain at baseline and at 4, 12, 26, and 52 weeks. Secondary measures were disability, health status, global perceived effect, medication use, and satisfaction. RESULTS: At 12 weeks, there was a significant difference in patient-rated pain between ET + SMT and HEA (1.3 points, P < 0.001) and ET and HEA (1.1 points, P = 0.001). Although there were smaller group differences in patient-rated pain at 52 weeks (ET + SMT vs. HEA, 0.2 points, P > 0.05; ET vs. HEA, 0.3 points, P > 0.05), linear mixed model analyses incorporating all time points yielded a significant advantage for the 2 supervised exercise groups (ET + SMT vs. HEA, P = 0.03; ET vs. HEA, P = 0.02). Similar results were observed for global perceived effect and satisfaction. CONCLUSION: Supervised strengthening exercise with and without spinal manipulation performed similarly, yielding better outcomes than home exercise particularly in the short term. Various stakeholders' perspectives should be considered carefully when making recommendations regarding these therapies, taking into account side effects, preferences, and costs.

Supervised exercise, spinal manipulation, and home exercise for chronic low back pain: a randomized clinical trial.

BACKGROUND CONTEXT: Several conservative therapies have been shown to be beneficial in the treatment of chronic low back pain (CLBP), including different forms of exercise and spinal manipulative therapy (SMT). The efficacy of less time-consuming and less costly self-care interventions, for example, home exercise, remains inconclusive in CLBP populations. PURPOSE: The purpose of this study was to assess the relative efficacy of supervised exercise, spinal manipulation, and home exercise for the treatment of CLBP. STUDY DESIGN/SETTING: An observer-blinded and mixed-method randomized clinical trial conducted in a university research clinic in Bloomington, MN, USA. PATIENT SAMPLE: Individuals, 18 to 65 years of age, who had a primary complaint of mechanical LBP of at least 6-week duration with or without radiating pain to the lower extremity were included in this trial. OUTCOME MEASURES: Patient-rated outcomes were pain, disability, general health status, medication use, global improvement, and satisfaction. Trunk muscle endurance and strength were assessed by blinded examiners, and qualitative interviews were performed at the end of the 12-week treatment phase. METHODS: This prospective randomized clinical trial examined the short- (12 weeks) and long-term (52 weeks) relative efficacy of high-dose, supervised low-tech trunk exercise, chiropractic SMT, and a short course of home exercise and self-care advice for the treatment of LBP of at least 6-week duration. The study was approved by local institutional review boards. RESULTS: A total of 301 individuals were included in this trial. For all three treatment groups, outcomes improved during the 12 weeks of treatment. Those who received supervised trunk exercise were most satisfied with care and experienced the greatest gains in trunk muscle endurance and strength, but they did not significantly differ from those receiving chiropractic spinal manipulation or home exercise in terms of pain and other patient-rated individual outcomes, in both the short- and long-term. CONCLUSIONS: For CLBP, supervised exercise was significantly better than chiropractic spinal manipulation and home exercise in terms of satisfaction with treatment and trunk muscle endurance and strength. Although the short- and long-term differences between groups in patient-rated pain, disability, improvement, general health status, and medication use consistently favored the supervised exercise group, the differences were relatively small and not statistically significant for these individual outcomes.

Physicians, guidelines, and cognitive tasks.

Using a case study analysis of the Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Treatment of Asthma, this article compares the workflows and knowledge requirements of primary care practice to the structure and content of a well-respected set of clinical guidelines. The authors show that there are discrepancies between physician workflow and the structure of the EPR-3, as well as between physicians' knowledge requirements and the content of the EPR-3. The analysis suggests that closing the gap between medical knowledge and practice will require alternative ways to represent guidelines' knowledge and recommendations.

Principal atrial fibrillation discharges by the new ACC/AHA/ESC classification.

BACKGROUND: The American College of Cardiology, American Heart Association, and European Society of Cardiology Board (ACC/AHA/ESC) 2001 guidelines for management of patients with atrial fibrillation (AF) include a new classification system consisting of 4 categories: first-detected episode; recurrent paroxysmal (self-terminating); recurrent persistent (requiring cardioversion); and permanent. The frequency of hospital discharges within these categories has not been reported. METHODS: The new classification system was applied to 135 consecutive hospital discharges with a principal diagnosis of AF. RESULTS: Classification of AF in these discharged patients included 74 (55%) with first-detected episode; 28 (21%) with recurrent paroxysmal AF; 17 (13%) with recurrent persistent AF; and 16 (12%) with permanent AF. Hypertension (n = 48; 35%) was the most common primary cause of AF, followed by alcohol related (n = 23; 17%), coronary artery disease (n = 20; 15%), and valvular heart disease (n = 17; 12%). For the 102 patients with first-detected and recurrent paroxysmal AF, 71 (69%) converted spontaneously to normal sinus rhythm within 48 hours of admission. Of the 48 patients with a discharge diagnosis of AF, 32 (67%) were receiving anticoagulation therapy. CONCLUSIONS: Most hospital discharges with a principal diagnosis of AF represent the first-detected episode. Diverse causes contribute to AF, and to examine them would help direct therapy. Importantly, in our analysis, 69% of those patients with first-detected or recurrent paroxysmal AF converted spontaneously to normal sinus rhythm within 48 hours of admission.

Cardiovascular manifestations of moderate to severe carbon monoxide poisoning.

OBJECTIVES: We describe the cardiovascular manifestations of carbon monoxide (CO) poisoning. BACKGROUND: Carbon monoxide poisoning is a common cause of toxicologic morbidity and mortality. Although the neurologic sequelae of CO poisoning have been well described, the cardiovascular consequences are limited to isolated case reports. METHODS: We reviewed the cardiovascular manifestations of 230 consecutive patients treated for moderate to severe CO poisoning in the hyperbaric oxygen chamber at Hennepin County Medical Center (HCMC), a regional center for treatment of CO poisoning. RESULTS: The mean age was 47.2 years with 72% men. Ischemic electrocardiogram (ECG) changes were present in 30% of patients, whereas only 16% had a normal ECG. Cardiac biomarkers (creatine kinase-MB fraction or troponin I) were elevated in 35% of patients. In-hospital mortality was 5%. CONCLUSIONS: Cardiovascular sequelae of CO poisoning are frequent, with myocardial injury assessed by biomarkers or ECG in 37% of patients. Patients admitted to the hospital with CO poisoning should have a baseline ECG and serial cardiac biomarkers.

Incidence of type 2 diabetes in the randomized multiple risk factor intervention trial.

BACKGROUND: Weight loss and increased physical exercise reduce the risk for diabetes in people with impaired glucose tolerance. Randomized trial evidence on the effect of these interventions on people without impaired glucose tolerance is lacking. OBJECTIVE: To examine the influence of a comprehensive intervention program on the risk for developing diabetes in men without impaired glucose tolerance and in a post hoc subgroup analysis by baseline cigarette smoking status. DESIGN: Randomized, controlled trial. SETTING: 22 clinical centers for the Multiple Risk Factor Intervention Trial (MRFIT). PARTICIPANTS: 12,866 men age 35 to 57 years at risk for cardiovascular disease were randomly assigned to either a special intervention or usual care group and followed for 6 to 7 years; this report focuses on 11,827 men without diabetes or impaired glucose tolerance at entry for whom follow-up glucose measurements were available. MEASUREMENTS: Cardiovascular disease risk factors, fasting blood glucose levels, and diabetes medication history were assessed before randomization and annually. INTERVENTION: Men in the special intervention group were counseled to change diet (reduce saturated fat, cholesterol, and calorie intake), to stop smoking, and to increase physical activity. Blood pressure was treated more intensively in the special intervention group than in the usual care group. RESULTS: 11.5% of the special intervention group and 10.8% of the usual care group developed diabetes over 6 years of follow-up (hazard ratio, 1.08 [95% CI, 0.96 to 1.20]). The special intervention-usual care hazard ratio for diabetes was 1.26 (CI, 1.10 to 1.45) among smokers (63%) and 0.82 (CI, 0.68 to 0.98) among nonsmokers (37%). These estimates differed significantly (P = 0.0003). Weight gain after smoking cessation and the use of antihypertensive drugs may have counterbalanced the beneficial effect of the lifestyle intervention for the special intervention group smokers, while the lifestyle intervention was beneficial among nonsmokers. LIMITATIONS: Principal findings are based on a post hoc subgroup analysis. CONCLUSIONS: In nonsmokers, an intervention program that included nutrition counseling to produce reductions in weight, serum cholesterol, and (along with antihypertensive medication) blood pressure reduced the risk for diabetes.

Patient visits to a hospital-based alternative medicine clinic from 1997 through 2002: experience from an integrated healthcare system.

OBJECTIVE: Efforts to integrate complementary and alternative medicine (CAM) into conventional healthcare systems raise questions about expected levels of CAM use and its cost in an integrated system. This paper documents actual patient usage of a hospital-based alternative medicine clinic that has been operating on a conventional healthcare campus since 1993. SETTING: Hennepin Faculty Associates (HFA) is a multispecialty physician organization serving the Hennepin County Medical Center (HCMC), a public teaching hospital in downtown Minneapolis. In 1993, HFA opened an alternative medicine clinic, primarily providing acupuncture. The clinic has since expanded services to offer chiropractic, massage/bodywork, and herbs. Administrative claims data showing visit dates, treatment received, payment source, charges, and patient complaints are available from 1997 through 2002. RESULTS: Of all HFA patients who received conventional care on the HCMC campus every year (1997-2002), 6.5% also received care at the Alternative Medicine Clinic (AMC). Nearly 80% of AMC patients received third-party reimbursement for AMC services. Averaged over 6 years, self-pay patients had 3.2 visits per year and incurred $173 in charges per year; patients with a mixture of third-party payment sources had 8.0 visits per year and incurred $634 in charges per year. Number of visits per patient per year remained relatively constant over the 6 years, except for patients aged 65 or older, who showed an increase in number of visits, particularly for acupuncture. CONCLUSIONS: This report contributes a new perspective on use of CAM in the general population. Results from this perspective differ markedly from those provided by published survey data, showing a lower prevalence of use and lower charges incurred. Concern that insurance coverage for CAM would increase healthcare costs dramatically are not substantiated by these data.